As is well known, the aging process frequently results in enlargement of the prostate which, in turn, constricts the prostatic urethra as the gland enlarges. This often seriously restricts the urine flow to levels below that which is acceptable, or even blocks it altogether.
In the TURP surgical procedure (Transurethral Resection, Prostate) prostatic tissue is removed to enlarge the urethra where it passes through the prostate. This is one of the most common surgical procedures performed in the United States today, particularly upon male patients of advanced age.
Following the surgery, the urologist conventionally inserts a "3-way" catheter into the patient's bladder in order to drain the bladder of urine and any introduced irrigating fluid during the patient's postoperative recovery. While such a catheter effectively drains the contents of the bladder, it unfortunately does not have any provision for drainage of the prostate in order to remove blood and/or particles of excised prostatic tissue from the gland that actually experienced the operative trauma. However, the spent irrigant is collected and periodically examined visually by the surgeon as he follows the post operative progress.
I, the inventor herein, recently underwent a TURP procedure at a major medical center in a major metropolitan area. Following the operation, the usual 3-way catheter was inserted and the constant drip flow of irrigating fluid initiated into the bladder. Although bloody at first, the collected spent fluid (urine and normal saline solution irrigant) rather quickly became clear and remained clear for a day or two prior to my departure from the hospital.
As I was being prepared for departure, the catheter was routinely removed. Upon removal of the catheter I was amazed and shocked by the nature of the resulting flow of fluid from the penis inasmuch as it contained a large amount of totally unexpected semi-coagulated blood and other waste material. This was in sharp contrast to the clear liquid which had been discharged from the catheter during the previous day or two. Clearly, the traumatized prostate had not been flushed successfully by the irrigation procedure; this, in spite of the fact that the hospital financial statement which I received as I departed indicated that I had consumed over 20 3-liter bags of saline solution to irrigate the bladder, at a unit price of $51.75. Accordingly, I was charged over $1100.00 for irrigation supplies which had not achieved the desired purpose. Considering the tens of thousands of TURP operations that are performed in the United States each year, the resulting economic waste and financial burden needlessly placed upon the patient are staggering, not to mention the poor therapeutic results obtained by not irrigating the prostate following surgery.
Investigation quickly revealed the root of the problem. I asked the nurse to clean up the catheter and give it to me for inspection. Upon examination, I immediately realized that the catheter was designed in such a way that the irrigation fluid was introduced into the bladder, on which no surgery had been performed, as opposed to the prostate, which had been severely traumatized by the surgery, but did not directly receive any irrigation.
In effect, the irrigating fluid was merely "short circuited" through the bladder. Immediately after being discharged into the bladder it entered the adjacent bladder drain holes in the catheter provided for that purpose. Accordingly, only an extremely small percentage of the fluid ever reached the area it was intended to reach and where it was required, i.e. the traumatized prostate area. By reason of not having any provision for irrigation and drainage, the prostate area merely collected stale urine, undesired blood products etc. for the duration of the time that I wore the catheter.
The foregoing observation is confirmed by consideration of FIG. 6 of the drawings, illustrating schematically the construction and manner of use of the standard "3-way" catheter system used in my hospital and which, my urologist assured me, was also used universally by hospitals throughout the nation. I confirmed this conclusion by research through the voluminous catalogs of the major U.S. hospital supply distributors. All of them illustrated and offered for sale for use after prostate surgery only the "3-way" style urinary catheter illustrated in FIG. 6.
As shown schematically in that figure, the male urinary anatomy involved comprises the urethra 14, the prostate 16, the bladder neck 20 and the bladder 22. Following prostate surgery, the prostate is left with a central cavity 18 of surgically resected tissue, which is the area it is desired to irrigate and flush.
To accomplish the latter purpose, the prior art assembly employed in the hospital experience described above comprises an elongated catheter tube 24 equipped with positioning means comprising a conventional fluid-inflated "Foley" balloon 26.
The proximal end of the catheter has an irrigation port 28 connected to a source of irrigation fluid (drip bag). It also has one or more drain ports 30 and 31 which connect to a receiving receptacle for urine and spent irrigating fluid.
It is clearly evident from the foregoing why, in my hospital experience, the prostate cavity was inefficiently irrigated, if it was irrigated at all. The irrigating fluid was introduced into the bladder through port 28 and promptly exited through adjacent ports 30 and 31, completely bypassing the prostate area.
It is to be noted that in the use of this style catheter, the bladder is placed in an imperfectly sealed relation to the prostate cavity by means of locating balloon 26. The only way for blood, urine and surgical debris to be removed from the prostate area is for it to leak past the balloon and exit via ports 30 and 31 in the bladder. Such leakage is minimal, however, due to the complete lack of any catheter irrigation and/or drainage facilities within the prostate, as well as because of the sealing action of the locating balloon.
In addition to largely inhibiting the flow of irrigation fluid from the bladder to the prostate area, the imperfect seal created by balloon 26 has another adverse effect. It permits urine from the bladder to leak into the surgically resected prostate and accumulate there without there being any provision for drainage until the catheter ultimately is removed.
It is true that small amounts of urine and other fluids which accumulate in the prostate can, under some circumstances, leak past the circumferential fit between the catheter and the urethra downstream from the prostate, particularly if the catheter is a loose fit. However, such amounts are not sufficient to irrigate the prostate. Additionally in practice, this leakage is discouraged. Quite often provision is made to seal against it, inasmuch as it results in patient discomfort and soiling of his bedding and/or clothing.
In any event, such leakage generally is not relied upon as a primary means of draining the prostate. For all practical purposes, the prostate does not have any provision for drainage when the 3-way catheter is in place. Most of the stale urine, blood products and debris is left to accumulate in the prostate cavity. There it is subject to biological degradation, until withdrawal of the catheter several days following surgery.
Accordingly, what is required is an easily applied and serviced urinary catheter assembly which has provision for flushing out the prostate area quickly, repeatedly, effectively and safely. It is the general object of the present invention to provide such an assembly and a method for its application.